Fees for assessment of clinical trials and assessment of safety information
Published:
Changes
The fees are applicable from January 1st 2023
| Type of application | Fee |
| New application - Norway as Reference Member State | 73.080 NOK |
| New application - Norway as Member State Concerned | 31.320 NOK |
| Application for Substantial Modification | 6264 NOK |
| Application for transition to regulation no. 536/2014 | No fee |
| Safety assessment - time spent > 5 days | 4176 NOK |
| Safety assessment - time spent < 5 days | 2088 NOK |
Applications
Invoice information must be uploaded to the "Proof of Payment" field under the "Forms" section of the application in CTIS.
An invoice will be sent after the application has been received. The invoice will include the EU CT number / EudraCT number as well as the DMP reference number.
Safety assessments
NoMA will send the sponsor an invoice once the annual safety report (ASR) is received. In case NoMA receives several ASRs for the same active substance by different sponsors, all sponsors will be charged separately.
Non-commercial sponsors
Non-commercial sponsors will not be charged any fees for clinical trial applications or safety assessments, therefore it is not necessary to upload any information/documents as proof of payment.